GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
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Pathology:<br />
F0 males and satellite females:<br />
Organ Weights:<br />
Significantly increased absolute liver weight and liver weight relative to brain weight in<br />
animals of the 500 and 1 000 mg/kg/day group.<br />
Significant findings in females only were decreased spleen weight (relative to brain<br />
weights) in the 1 000 mg/kg/day group and increased kidney weight in the 500 mg/kg/day<br />
group.<br />
Macroscopic:<br />
In males, pitted kidneys were observed in the 500 and 1 000 mg/kg/day groups.<br />
Microscopic:<br />
Treatment related effects were observed in kidneys of all test males (dose-related increased<br />
eosinophillic hyaline droplets in the proximal convoluted tubules, a finding commonly<br />
associated with hydrocarbon nephropathy). Minimal to moderate hepatocellular<br />
vacuolation was observed in animals of the 500 and 1 000 mg/kg/day groups.<br />
F0 females:<br />
Macroscopic:<br />
No test related findings were observed. The animal euthanised on post breeding Day 25<br />
was found to be non gravid. The animal euthanised on Day 43 was found to have<br />
implantation sites.<br />
Fertility, Gestation, Parturition and Lactation:<br />
Mating and fertility indices, precoital intervals and gestation length were comparable<br />
among the groups.<br />
F1 generation findings:<br />
No treatment related developmental effects through to lactation Day 4.<br />
Result:<br />
Based upon liver weight increase and hepatocyte cytoplasmic vacuolation observed at 500<br />
and 1 000 mg/kg/day, the No Observed Adverse Effect Level (NOAEL) determined for<br />
systemic toxicity in satellite females was 100 mg/kg/day. No NOAEL for systemic toxicity<br />
was established for males because of the presence of hydrocarbon nephropathy noted at all<br />
dose levels. The NOAEL for reproductive developmental or neurotoxicity was 1 000<br />
mg/kg/day in both males and females.<br />
9.2.4 Repeat Dose 13 Week Oral Toxicity Study in Rats Followed by a 4 Week<br />
Recovery Period using C20-C24 Alkenes, Branched and Linear (Huntingdon Life<br />
Sciences Limited 1999)<br />
Test Substance: C20-C24 Alkenes, Branched and Linear<br />
Species/strain: Rat/Crl:CD BR<br />
Method of administration: Oral (gavage)<br />
Dose/Study duration: 0, 100, 500, 1 000 mg/kg/day for 13 weeks followed by a<br />
FULL PUBLIC REPORT 26 April 2000<br />
NA/713 Page 65 of 100